A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthcare provider diagnosis of inflammatory bowel disease
- Report current symptoms
- Able to read and write in English
Exclusion Criteria:
- Live outside of Washington state
- Bowel-related surgery within the past month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Comprehensive Self-Management
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse. |
In addition to standard care, participants receive content on self-management which includes cognitive behavioral therapy, relaxation, and diet. Weekly phone calls provide support for achieving the sessions goals. |
|
Other: Usual care group
The control group will receive standard care without the comprehensive self-management intervention. |
The control group will receive standard care. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Feasibility
Time Frame: From screening to enrollment, an average of one month
|
Percentage comprised of number of participants enrolled divided by the number of participants approached. |
From screening to enrollment, an average of one month
|
|
Intervention Feasibility
Time Frame: 3 months
|
Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5). Range: 1 to 5. A higher score indicates greater feasibility. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline, 3 months, 6 months
|
Short Inflammatory Bowel Disease Questionnaire is a 10-item questionnaire which evaluates quality of life. Participants respond on a 7-item Likert scale from all the time to none of the time. Total score range: 10 to 70. A higher score indicates greater quality of life. |
Baseline, 3 months, 6 months
|
|
Change in Abdominal Pain Symptoms
Time Frame: Baseline, 3 months, 6 months
|
Abdominal pain was measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10). |
Baseline, 3 months, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy for Managing Chronic Disease
Time Frame: Baseline, 3 months, 6 months
|
A 6-item self-report scale. Participants report ranging from not at all confident to totally confident. Range: 1-10. A higher score indicates greater self-efficacy |
Baseline, 3 months, 6 months
|
|
Index of Self-Regulation
Time Frame: Baseline, 3 months, 6 months
|
A 9-item scale to measure individual's level of self-regulation. Range: 0-36. A higher score indicates greater self-regulation. |
Baseline, 3 months, 6 months
|
|
Patient Activation Measure
Time Frame: Baseline, 3 months, 6 months
|
A 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health. Range: 0-100. A higher score indicates greater activation. |
Baseline, 3 months, 6 months
|
|
Fecal Calprotectin
Time Frame: Baseline, 3 months
|
Number of Participants with Inactive Disease based on fecal calprotectin (<150 µg/g) assessed using ELISA. |
Baseline, 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kendra Kamp, PHD, RN, University of Washington
Publications and helpful links
General Publications
- Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy RL, Dey N, Lee S, Keefer L, Heitkemper M. A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 7;12:e46307. doi: 10.2196/46307.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00015210
- 1K23NR020044-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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